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Gastric CancerPhase 1NCT05327231

IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma

A Phase 1 study testing IN10018 and Docetaxel in people with Gastric Cancer, run by InxMed (Shanghai) Co., Ltd. at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I, multi-center clinical trial to evaluate the safety, tolerability, antitumor activities and pharmacokinetics of IN10018 as monotherapy or in combination with docetaxel in previously-treated locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
IN10018 and Docetaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
8 sitesChina
Study dates
9 Jul 2020to 31 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Has histologically or cytologically confirmed diagnosis of locally advanced and/or metastatic gastric or GEJ adenocarcinoma.
  • For monotherapy, participants need to be failed to respond to standard therapy or standard or curative therapy does not exist or is not tolerable.
  • For combination therapy, participants need to have disease progression within 3 months after at least first-line therapy.
  • 2.Has at least one measurable tumor lesion per RECIST 1.1.
  • 3.Has an ECOG performance status of 0 or 1.
  • 4.Estimated life expectancy is more than 3 months.
  • 5.Adequate organ and bone marrow functions.
  • 6.Has been fully informed and provided written informed consent for the study

Who cannot join

  • 1.Has other histological types other than adenocarcinoma.
  • 2.For participants with HER2/neu positive tumors or have an unknown tumor status, need to match the following:
  • If HER2/neu positive, participant must have documentation of disease progression on trastuzumab or other anti-HER2/neu therapy.
  • Participants with unknown status must have their HER2/neu status determined locally. If HER2/neu-negative, the participant will be eligible. If HER2/neu-positive, the participant must have documentation of disease progression on trastuzumab or other anti-HER2/neu therapy.
  • 3.Has had disease progression after docetaxel/paclitaxel containing treatment (combination therapy only).
  • 4.Has received prior systemic therapies (i.e. chemotherapy, biotherapy, endocrinotherapy, and immunotherapy) within 4 weeks prior to start of study treatment.
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  • 5.Has received prior radiotherapy within 2 weeks prior to start of study treatment.
  • 6.Has severe allergy or hypersensitivity to IN10018 and/or docetaxel, or any components used in their preparation or has contraindication for taxane therapy. For participants in monotherapy group, only restriction to IN10018 applies.
  • 7.Has severe renal disease or impaired renal function.
  • 8.Has an active infection requiring systemic therapy within 2 weeks prior to start of study treatment.
  • 9.Has a history or current evidence of interstitial lung disease.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Anyang Tumor Hospital

    Anyang, Henan

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of XI 'AN Jiaotong University

    Xi’an, Shanxi

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase I, Open-label Clinical Trial to Evaluate Safety, Tolerability, Antitumor Activities and Pharmacokinetics of IN10018 as Mono or Combination Therapy in Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This is a phase I, multi-center clinical trial to evaluate the safety, tolerability, antitumor activities and pharmacokinetics of IN10018 as monotherapy or in combination with docetaxel in previously-treated locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Read the detailed description

Eligibility patients will be enrolled into the study and assigned to treatment groups: 1) IN10018 monotherapy group, and 2) IN10018+Docetaxel combination group. This study contains 2 parts of dose escalation and dose expansion for each treatment group. The monotherapy group will enroll patients failed to respond to standard therapy or standard or curative therapy does not exist or is not tolerable, and explore IN10018 monotherapy RP2D with the starting dose of IN10018 100mg QD per 3+3 design. The combination group will enroll patients who have disease progression within 3 months after at least first-line therapy, and explore IN10018+docetaxel RP2D with the starting dose of IN10018 100mg QD + docetaxel 75mg/m2 per 3+3 design. The dose expansion part will start after attaining the RP2D of IN10018 monotherapy and IN10018+docetaxel combination therapy.

Conditions
Gastric Cancer
Being tested
IN10018, Docetaxel
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IN10018Drug

    IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.

  • DocetaxelDrug

    Docetaxel 75mg/m2 every 21 days a cycle.

Study groups in NCT05327231
Study groupRoleWhat they receive
IN10018 MonotherapyExperimentalParticipants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
Receives: Drug: IN10018
IN10018 Combination with DocetaxelExperimentalParticipants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours. Docetaxel 75mg/m2 every 21 days a cycle.
Receives: Drug: IN10018; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability in combination group

    Number of patients with adverse event in combination group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in combination group

    Measured: up to 24 months

  2. DLTs in combination group

    Number of patients with dose-limited toxicities (DLTs) in combination group

    Measured: 21 days

  3. Phase II dose of IN10018 in combination with Docetaxel

    Determine the recommended phase II dose (RP2D) of IN10018 in combination with Docetaxel

    Measured: up to 24 months

Secondary outcomes (14)

  1. Safety and tolerability in IN10018 monotherapy group

    Number of patients with adverse event in monotherapy group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in monotherapy group

    Measured: up to 24 months

  2. DLTs in IN10018 monotherapy group

    Number of patients with dose-limited toxicities (DLTs) in monotherapy group

    Measured: up to 24 months

  3. Objective response rate (ORR) per RECIST v1.1

    Defined as the proportion of patients with complete response (CR) or partial response (PR).

    Measured: up to 24 months

  4. Duration of objective response (DOR) per RECIST v1.1.

    Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first

    Measured: up to 24 months

  5. Disease Control Rate (DCR) per RECIST v1.1.

    Defined as the proportion of patients with CR, PR, or stable disease (SD)

    Measured: up to 24 months

  6. Progression-free survival (PFS) per RECIST v1.1.

    Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.

    Measured: up to 24 months

  7. Overall survival (OS).

    Defined as the time from the start of any study treatment to the date of death due to any cause.

    Measured: up to 30 months

  8. Pharmacokinetics (PK):AUC

    Area under the concentration-time curve (AUC).

    Measured: up to 24 months

  9. Pharmacokinetics (PK):Cmax

    PK: Maximum concentration (Cmax).

    Measured: up to 24 months

  10. PK:Tmax

    Time to Cmax (Tmax).

    Measured: up to 24 months

  11. PK:Ctrough

    Trough concentration (Ctrough).

    Measured: up to 24 months

  12. PK:t1/2

    Elimination half-life (t1/2).

    Measured: up to 24 months

  13. PK:CL/F

    apparent clearance (CL/F).

    Measured: up to 24 months

  14. PK:Vd/F

    Apparent volume of distribution (Vd/F).

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start9 Jul 2020
  3. Primary completion3 Dec 2021
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05327231
Sponsor's protocol ID
IN10018-003
Status last verified
Sep 2022
First submitted
29 Mar 2022
Last updated
16 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IN10018 and Docetaxel in people with Gastric Cancer, run by InxMed (Shanghai) Co., Ltd. at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability in combination group (time frame: up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05327231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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